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Myriad Genetics' Cancer Companion Diagnostic Test Gets FDA Nod

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Myriad Genetics, Inc. MYGN received the FDA clearance for its BRACAnalysis CDx, which is to be used as a companion diagnostic test by care providers to identify patients with metastatic pancreatic cancer. Notably, the identified patients will only be able to avail the test if they have a germline BRCA mutation and are eligible to be treated with PARP inhibitor Lynparza (olaparib).

Notably, the BRACAnalysis CDx (an in vitro diagnostic device) is the first and only FDA-approved genetic test to identify metastatic pancreatic cancer in patients. For investor’s note, Lynparza is jointly marketed by AstraZeneca AZN and Merck (also known as MSD outside of the United States and Canada).

Myriad Genetics has been partnering with AstraZeneca since 2007 to receive various regulatory clearances for BRACAnalysis CDx, thus enabling more patients to benefit from treatment with olaparib.

With the approval, Myriad Genetics aims to globally strengthen its Hereditary Cancer testing business, an arm of the broader Molecular Diagnostic Testing segment.



 

Significance of the Clearance

Per the company, the regulatory clearance of the PARP inhibitor Lynparza and the subsequent expansion of the use of BRACAnalysis CDx as a companion diagnostic test is a step toward enhancing cancer care.

Pancreatic cancer is currently the third most common cause of cancer-related deaths in the United States. In view of such a scenario, the approval along with the updated National Comprehensive Cancer Network (NCCN) is significant because these will provide better treatment options to clinicians, who order testing at the time of diagnosis. Myriad Genetics believes that early diagnosis of patients with germline BRCA mutations will benefit the patients through precision therapies.

Industry Prospects

Per a report by The INSIGHT Partners, the global hereditary cancer testing market was at $3,967.7 million in 2018. It is expected to reach $9,840.5 million by 2027, witnessing a CAGR of 11.1% between 2019 and 2027. Certain factors like increasing prevalence and awareness about hereditary cancer, and advancements in the diagnosis type are expected to drive the market.

Given the growing potential of the market, the FDA approval has been well-timed.

Recent Developments in Molecular Diagnostic Testing

Myriad Genetics presented favorable study results on its polygenic risk score (PRS) for breast cancer in December 2019. The key focus of the validation study was to prove the significant improvement in precision and accuracy of breast cancer risk estimates in women of European ancestry having pathogenic variants (PV) in high and moderate-penetrance breast cancer genes.

The company received Japan’s Ministry of Health, Labour and Welfare’s (MHLW) approval for the BRACAnalysis Diagnostic System (BRACAnalysis) in November 2019. The system will be used to help care providers identify women with breast cancer, having Hereditary Breast and Ovarian Cancer (HBOC) syndrome, and qualifying for additional medical management.

In October 2019, the company received the FDA approval for its myChoice CDx to be used as a companion diagnostic by care providers. The test will help identify women with advanced ovarian cancer, who are eligible for GlaxoSmithKline plc’s (GSK - Free Report) Zejula (niraparib) PARP Inhibitor in the late-line treatment setting.

Price Performance

In a year, shares of Myriad Genetics have declined 8.8% against the industry’s 7.7% growth.

Zacks Rank & Stock to Consider

Currently, Myriad Genetics carries a Zacks Rank #4 (Sell).

A better-ranked stock from the broader medical space is Haemonetics Corporation HAE.

Haemonetics has a projected long-term earnings growth rate of 13.5%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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